FDA approves generic EpiPen, paving way for more affordable access to lifesaving treatment

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ST. GEORGE  The U.S. Food and Drug Administration has approved the first generic versions of the epinephrine “EpiPen” and “EpiPen Jr” auto-injectors, which officials say will grant more affordable access to emergency treatment of allergic reactions.

“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” FDA Commissioner Scott Gottlieb said in a press release issued by the FDA.

The EpiPen can help those suffering from life-threatening reactions – anaphylaxis – and is approved for adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA received approval to market the generic epinephrine auto-injectors in 0.3- and 0.15-milligram strengths.

This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option as well as another approved product to help protect against potential drug shortages,” Gottlieb said,

FDA-approved epinephrine auto-injector products include EpiPen, Adrenaclick and Auvi-Q. Additional “authorized generic” versions of EpiPen and Adrenaclick are marketed without the brand names. They are made using the same formulation, process and manufacturing facilities used by the brand name manufacturer and are often sold at a lower cost.

As with brand-name drugs, the FDA inspects manufacturing and packaging facilities for generic drugs to ensure that they are capable of consistently producing quality products.

Life-threatening allergies that the EpiPen is designed to address can include reactions to insect bites or stings, foods, medications, latex or other causes. Anaphylaxis is a medical emergency that affects the whole body and, in some cases, leads to death.

Anaphylaxis occurs in approximately 1 in 50 Americans. People who have had an anaphylaxis episode always face the risk of another one. Because of this risk, these patients must carry one or more emergency doses of epinephrine at all times.

The EpiPen is designed to automatically inject a dose of epinephrine into a person’s thigh to stop an allergic reaction. When given intramuscularly or subcutaneously, it works by reducing swelling in the airway and increasing blood flow in the veins.

Gottlieb said the FDA has been working to prioritize the approval of additional medicines with little or no generic competition and remove barriers to generic development.

“Many of these steps were outlined in our Drug Competition Action Plan, announced last year,” he said. “We’re especially committed to the development of generic copies of complex products.”

The FDA says it is advancing new guidance for drug makers in order to make developing generic versions of these more complex pharmaceutical products more efficient, and it is currently prioritizing review of many other complex generic drug applications.

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